UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046819 |
|---|---|
| Receipt number | R000053396 |
| Scientific Title | A study of clinical utility on biological data collection using multi-healthcare devices in cancer patients treated with chemotherapy |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2024/02/06 15:14:17 |
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Basic information
Public title
A study of clinical utility on biological data collection using multi-healthcare devices in cancer patients treated with chemotherapy
Acronym
A study of clinical utility on biological data collection using multi-healthcare devices in cancer patients treated with chemotherapy
Scientific Title
A study of clinical utility on biological data collection using multi-healthcare devices in cancer patients treated with chemotherapy
Scientific Title:Acronym
A study of clinical utility on biological data collection using multi-healthcare devices in cancer patients treated with chemotherapy
Region
| Japan |
Condition
Condition
gastric cancer, colorectal cancer, pancreatic cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To consider feasibility of multi-healthcare device and utility on biological data collection using the device.
Basic objectives2
Others
Basic objectives -Others
To examine the existence of association between collected biological data and adverse events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of stress data from start to stop of treatment or 12 weeks after, whichever comes first
Key secondary outcomes
Success rate of collecting biological data and stress data using multi-healthcare device
Association between biological data or stress data and adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with gastric, colorectal and pancreatic cancer who plan to start chemotherapy including adjuvant and palliative treatment.
Patients who have never received chemotherapy.
Patients aged 20 years or older with PS 0-2.
Key exclusion criteria
Patients with psychiatric illness or cognitive dysfunction.
Patients who use medical device with electric wave.
Cases that the researcher evaluate inappropriate for participating in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Doi |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae0ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
adoi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Naho |
| Middle name | |
| Last name | Kobayashi |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae0ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
n2koba@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Canon Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine bioethics committee
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective obserbational study
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053396
